Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The American Orthopedic Foot and Ankle Score
研究概览
简要总结
This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle joint cartilage lesions compared to the conventional microfracture method. It involves 40 participants aged 18 to 65 with localized cartilage defects (Outerbridge II-IV) in the ankle's talus bone.
Participants will be divided into two groups: the main group and the control group. The main group will undergo a two-stage process. Initially, adipose tissue will be collected via lipoaspiration from osteoarthritis patients. This tissue will be used to isolate mesenchymal stem cells (MSCs) and extract growth factors, resulting in a biocomposite hydrogel. In the second stage, arthroscopy will be performed to apply the hydrogel for cartilage treatment.
The control group will undergo standard microfracture surgery, a known cartilage repair method.
The study's main objective is to compare heparin-conjugated gel treatment to microfracture in terms of cartilage repair and patient outcomes. A 12-month follow-up will assess short-term and potential mid-term effects.
Data will be analyzed using Microsoft Excel and Statistica 13.0 for descriptive and comprehensive statistical analysis. Quantitative indicators will be assessed using appropriate tests (Mann-Whitney, Wilcoxon T, χ2) to determine significant differences between groups.
The study addresses key questions: Does heparin-conjugated gel offer better cartilage repair, functional improvement, and pain reduction than microfracture? Does the hydrogel approach better preserve joint integrity and slow degeneration? Are there complications with either method? This study combines cellular and surgical components to explore innovative cartilage lesion treatments. Comparing with microfracture and using a thorough follow-up, it aims to enhance cartilage repair techniques and patient outcomes.
详细描述
Introduction:
This prospective clinical study aims to investigate the effectiveness of heparin-conjugated gel in treating patients with ankle joint cartilage lesions and to compare its outcomes with the traditional method of microfracture. The study aims to provide valuable insights into novel treatment options for cartilage repair.
Study Design and Participants:
The study plans to enroll 40 male and female patients aged 18 to 65 years with localized defects in the articular cartilage of the talus bone (Outerbridge II-IV) within the ankle joint. Participants will be evenly divided into two groups: the main group and the control group, each comprising 20 participants.
Interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a local defect of articular cartilage of the talus bone (Outerbridge II-IV) of the ankle joint;
- •an area of no more than 3 cm2 for a single defect or 20 cm2 for multiple defects of the cartilaginous tissue of the talus bone of the ankle joint;
- •voluntary consent to participate in the study.
排除标准
- •age 18< and >65
- •progressive osteoarthritis of the ankle joint in the late stages;
- •synovitis of the ankle joint;
- •instability of the ankle joint;
- •BMI<29.9;
- •presence of non-sanitized foci of chronic infection;
- •severe mental illnesses (schizophrenia, psycho-organic syndrome);
- •hormonal osteopathy;
- •hemiparesis on the side of the proposed operation;
- •neoplasms of other localizations with or without metastases;
- •absence (refusal) of voluntary consent to participate in the study.
结局指标
主要结局
The American Orthopedic Foot and Ankle Score
时间窗: 6; 12 months after surgery
The American Orthopedic Foot and Ankle Score (AOFAS) is a widely used outcome measure designed to assess the functional status and pain levels of patients with foot and ankle disorders. It provides a standardized way to quantify the impact of musculoskeletal conditions on patients' daily lives. The AOFAS score involves a questionnaire that includes various domains related to pain, function, and alignment of the foot and ankle. The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.
Visual Analogue Scale
时间窗: 6; 12 months after surgery
The Visual Analog Scale (VAS) is a reliable subjective tool used to assess both acute and chronic pain. Individuals express their pain levels by placing a mark on a 10-centimeter line, visually representing a spectrum ranging from "no pain" to "worst pain". Ratings are derived from self-reported symptoms, where individuals use a single handwritten mark on a 10-centimeter line. This line signifies a spectrum between "no pain" at the left end (0 cm) and the utmost level of pain at the right end (10 cm).
次要结局
- Magnetic resonance imaging of ankle(6; 12 months after surgery)
- C-reactive protein(5 days after surgery)
- Complete Blood Count(5 days after surgery)